BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4151380 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03908
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE OF L3-4, L4-5 AND UNDERWENT DIRECT LATERAL INTERBODY FUSION(L3-4,L4-5) WITH PERCUTANEOUS PEDICLE SCREW FIXATION. THERE WERE NO COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR LUMBAR FUSION AT L3-4, L4-5 USING RHBMP-2/ACS PLACED INSIDE OF A PEEK CAGE. FOLLOWING THE SURGERY, THE PATIENT DEVELOPED FURTHER BACK PAIN. CONSEQUENTLY, THE PATIENT UNDERWENT ADDITIONAL IMAGING. CT SCANS PERFORMED IN 2011 AND 2013 DEMONSTRATED THAT THE PATIENT HAD DEVELOPED ECTOPIC BONE GROWTH. THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY, AND HE HAS DAILY, DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632379 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110805AAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other